Pen Needle 320618Recalls & reported problems
Wal-Mart Stores, Inc. · ReliOn Pen Needles 4mm x 32 Gauge (5/32" x 0.23mm) Pen Needles 50 count · Class 2
Quick summary
These ReliOn pen needles are single-use hypodermic needles for insulin pens. The 39 reports mostly describe needles clogging, failing to attach, bending or breaking, sometimes causing a needle stick. There were 39 reports, no deaths, and 1 injury. No recalls name this device. Reports fell to 0 in the last 12 months from 5 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00681131386791), received between Sep 20, 2022 and Sep 29, 2026 — classified as 1 injury, 59 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (27 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Deliver27
- Device Markings/Labelling Problem19
- Break4
- Misconnection3
- Off-Label Use2
- Defective Device1
- Delivered as Unsterile Product1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions60
- Needle Stick/Puncture1
- Pain1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930153 ↗MalfunctionSep 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929530 ↗MalfunctionSep 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929513 ↗MalfunctionSep 29, 2026Device Markings/Labelling Problem
Spouse of consumer reported mixed product, stated that there were pen needles with gray covers in her box of 4mm pen needles.She stated that she discarded the needles when she saw that they were different. She also stated that her husband has never used needles with gray covers.Caller also reported that there were about 20 needles in the same box that were shorter than the 4mm that her husband is using. She believes that the needles are too short and does not go far enough into the skin.I advised consumer that the 4mm pen needles are the shortest and finest needle that we manufacture.Lot #: 3058981Catalog #: 320618Date of Event: unknownSamples: available - sending mail kitThis intake record was reviewed as part of CAPAs #(b)(4) and #(b)(4) and deficiencies were identified. The following actions were taken, "[Nineteen additional complaint records were created for Dimension.]". With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929501 ↗MalfunctionSep 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929368 ↗MalfunctionSep 29, 2026Device Markings/Labelling Problem
Spouse of consumer reported mixed product, stated that there were pen needles with gray covers in her box of 4mm pen needles.She stated that she discarded the needles when she saw that they were different. She also stated that her husband has never used needles with gray covers.Caller also reported that there were about 20 needles in the same box that were shorter than the 4mm that her husband is using. She believes that the needles are too short and does not go far enough into the skin.I advised consumer that the 4mm pen needles are the shortest and finest needle that we manufacture.Lot #: 3058981Catalog #: 320618Date of Event: unknownSamples: available - sending mail kitThis intake record was reviewed as part of CAPAs #(b)(4) and #(b)(4) and deficiencies were identified. The following actions were taken, "[Nineteen additional complaint records were created for Dimension.]". With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929258 ↗MalfunctionSep 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929178 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917664 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917584 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917282 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916997 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916880 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Spouse of consumer reported mixed product, stated that there were pen needles with gray covers in her box of 4mm pen needles.She stated that she discarded the needles when she saw that they were different. She also stated that her husband has never used needles with gray covers.Caller also reported that there were about 20 needles in the same box that were shorter than the 4mm that her husband is using. She believes that the needles are too short and does not go far enough into the skin.I advised consumer that the 4mm pen needles are the shortest and finest needle that we manufacture.Lot #: 3058981.Catalog #: 320618.Date of Event: unknown.Samples: available - sending mail kit.This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken, "[Nineteen additional complaint records were created for Dimension.]". With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916625 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916354 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915971 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Spouse of consumer reported mixed product, stated that there were pen needles with gray covers in her box of 4mm pen needles.She stated that she discarded the needles when she saw that they were different. She also stated that her husband has never used needles with gray covers.Caller also reported that there were about 20 needles in the same box that were shorter than the 4mm that her husband is using. She believes that the needles are too short and does not go far enough into the skin.I advised consumer that the 4mm pen needles are the shortest and finest needle that we manufacture.Lot #: 3058981Catalog #: 320618Date of Event: unknownSamples: available - sending mail kit------------------------------------------------------------------------------------------------------------This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken, "[Nineteen additional complaint records were created for Dimension.]". With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate even
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913673 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Spouse of consumer reported mixed product, stated that there were pen needles with gray covers in her box of 4mm pen needles.She stated that she discarded the needles when she saw that they were different. She also stated that her husband has never used needles with gray covers.Caller also reported that there were about 20 needles in the same box that were shorter than the 4mm that her husband is using. She believes that the needles are too short and does not go far enough into the skin.I advised consumer that the 4mm pen needles are the shortest and finest needle that we manufacture.Lot #: 3058981.Catalog #: 320618.Date of Event: unknown.Samples: available - sending mail kit.------------------------------------------------------------------------------------------------------------This intake record was reviewed as part of CAPAs #(b)(4) and #(b)(4) and deficiencies were identified. The following actions were taken, "[Nineteen additional complaint records were created for Dimension.]". With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate even
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912855 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Spouse of consumer reported mixed product, stated that there were pen needles with gray covers in her box of 4mm pen needles.She stated that she discarded the needles when she saw that they were different. She also stated that her husband has never used needles with gray covers.Caller also reported that there were about 20 needles in the same box that were shorter than the 4mm that her husband is using. She believes that the needles are too short and does not go far enough into the skin.I advised consumer that the 4mm pen needles are the shortest and finest needle that we manufacture.Lot #: 3058981Catalog #: 320618Date of Event: unknownSamples: available - sending mail kit------------------------------------------------------------------------------------------------------------This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken, "[Nineteen additional complaint records were created for Dimension.]". With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate even
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912616 ↗MalfunctionSep 24, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882757 ↗MalfunctionSep 24, 2026Failure to Deliver
Consumer reported, no insulin flow when priming pen needles. 5 pen needles affected. Lot: 3058981. Catalog: 320618.Date of Event: Unknown. Samples: Yes CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882243 ↗MalfunctionSep 24, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882108 ↗MalfunctionAug 25, 2025Off-Label Use; Failure to Deliver; Off-Label Use; Failure to Deliver
CONSUMER REPORTED NEEDLE CLOG DURING INJECTION. HE STATED THAT THE PEN WILL NOT DEPRESS. CONSUMER DOES NOT PRIME. CONSUMER DOES NOT RE-USE. LOT #: 4003011. CATALOG #: 320618. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22884318 ↗MalfunctionJun 10, 2025Off-Label Use; Off-Label Use
SPOUSE OF CONSUMER REPORTED NEEDLES BEND DURING INJECTION. SPOUSE STATED THAT THE CONSUMER RE-USES THE NEEDLES, BUT NEVER HAD AN ISSUE WITH OTHER BRANDS. CONSUMER REFUSED REPLACEMENT. I ADVISED HER THAT THE NEEDLES SHOULD BE USED ONLY ONCE. LOT #: 3305033 CATALOG #: 320618 DATE OF EVENT: UNKNOWN SAMPLES: DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176796 ↗MalfunctionMar 10, 2025Misconnection; Delivered as Unsterile Product; Misconnection; Delivered as Unsterile Product
CONSUMER REPORTED THE "TEAR DROP LABEL" WAS MISSING FROM 3 PEN NEEDLES BEFORE USE. STATED, SHE STILL TRIED TO USE THEM BUT THEY WOULD NOT ATTACH TO HER INSULIN PEN. LOT: 3305030. CATALOG: 320618. DATE OF EVENT: 2025-13-02. SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21559588 ↗MalfunctionMar 3, 2025Defective Device; Defective Device
CONSUMER REPORTED ON WALMART REPORT OTC (B)(4) - FOR THE PAST 10 DAYS HAVING ISSUES GETTING THE RELION 4MM PEN NEEDLES OFF HER PEN. CONSUMER HAS ALSO STUCK HERSELF TRYING TO GET THIS TO WORK. (REPORT ATTACHED) DATED 02.06.2025DC LOT # 3284018 CATALOG# 320618 DATE OF EVENT 01.20.2025 SAMPLE STATUS DISCARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21505458 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.